Title 21 CFR Part 11 Compliance

Code of Federal Regulations, Title 21

The Department of Health and Human Services frequently revises the Code of Federal Regulations, Title 21. This compliance regulates the criteria under which agencies store electronic records, electronic signatures, and handwritten signatures in electronic records. These records must be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.

For more information and the most update to date version of this code, please visit: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11.

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